2018
Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. The BMJ 2018, 360: k831. PMID: 29555641, PMCID: PMC5858606, DOI: 10.1136/bmj.k831.Peer-Reviewed Original ResearchConceptsOff-patent drugsObservational studyRare diseasePrescription drugsPatent drugsStudy drugTotal Medicaid spendingCardiovascular diseaseOrphan drug designationPsychiatric diseasesDrug AdministrationPatient accessInfectious diseasesDiseaseDrug characteristicsEssential medicinesDrugsGeneric versionsGeneric drugsMedicaid spendingNovel tabletRegulatory agenciesFDAUnited StatesTreatment area
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority